Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

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The US FDA has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic oHCM, available in second half of Jan 2026 through a restricted program via REMS
Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min, consistent across all subgroups & in pts with or without background beta-blocker therapy. Results were published in The NEJM
Myqorzois also being evaluated in the P-III (ACACIA-HCM) trial in pts with non-obstructive HCM (nHCM) & CEDAR-HCM, in a pediatric population with oHCM

Ref: Globenewswire| Image: Cytokinetics |Press Release

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